Crohn's DiseasesNCT07600255
Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease
An observational study of Crohn's Diseases, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Diseases
- Type of treatment
- Injection or infusion
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 20 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Crohn's disease (CD) is a chronic, progressive, transmural inflammation that can involve various parts of the oral to anal digestive tract.
Who may be able to join
- 1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks
Who cannot join
- UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs
- complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors
- combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases
- pregnancy or lactation
- Clinical data missing > 30%
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.
- Conditions
- Crohn's Diseases
- Keywords
- Crohn's Disease, Ustekinumab, individualized therapy, deep remission
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Each patient received an initial full-dose intravenous infusion of UST (6 mg/kg). At week 8, the clinical response was assessed based on the HBI. The patients who did not achieve clinical response [defined as a decrease in HBI < 3 from baseline, or remaining in moderate-to-severe clinical activity (HBI ≥ 8)] continued to receive intravenous UST infusions. The others who achieved clinical response at week 8 were switched to subcutaneous injections of 90 mg UST, followed by maintenance therapy with subcutaneous 90 mg UST every 8 weeks. During the follow-up period from week 8 to week 44, the PRO2 score was applied to monitor patients' response status. The patients who developed secondary loss of response (defined as liquid stool frequency ≥ 4 times/day or abdominal pain score ≥ 2) were re-administered intravenous UST infusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
deep remission rate at 44 week
At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated.
Measured: at 44 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jan 2021
- Primary completion1 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600255
- Sponsor's protocol ID
- SAHoWMU-CR2026-01-210
- Status last verified
- Apr 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT07600255
- Acronym / sponsor ID
- SAHoWMU-CR2026-01-210
- Conditions
- Crohn's Diseases
- Keywords
- Crohn's Disease, Ustekinumab, individualized therapy, deep remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –Each patient received an initial full-dose intravenous infusion of UST (6 mg/kg). At week 8, the clinical response was assessed based on the HBI. The patients who did not achieve clinical response [defined as a decrease in HBI < 3 from baseline, or remaining in moderate-to-severe clinical activity (HBI ≥ 8)] continued to receive intravenous UST infusions. The others who achieved clinical response at week 8 were switched to subcutaneous injections of 90 mg UST, followed by maintenance therapy with subcutaneous 90 mg UST every 8 weeks. During the follow-up period from week 8 to week 44, the PRO2 score was applied to monitor patients' response status. The patients who developed secondary loss of response (defined as liquid stool frequency ≥ 4 times/day or abdominal pain score ≥ 2) were re-administered intravenous UST infusions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's disease (CD) is a chronic, progressive, transmural inflammation that can involve various parts of the oral to anal digestive tract.
Key inclusion criteria (1 listed)
- 1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks
Key exclusion criteria (5 listed)
- UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs
- complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors
- combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases
- pregnancy or lactation
- Clinical data missing > 30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
deep remission rate at 44 week
Time frame: at 44 week
At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Diseases, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deep remission rate at 44 week (time frame: at 44 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.